Non-invasive Detection of Iron Deficiency in Obstetrics

NCT ID: NCT07083492

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2026-12-31

Brief Summary

Validation of non-invasive measurement of zinc protoporphyrin for detection of iron deficiency in pregnancy.

In addition, the impact of iron deficiency on the incidence of postpartum depression, restless legs syndrome, obstetric complications and quality of life will be examined.

Detailed Description

Study Title Point-of-care transcutaneous longitudinal non-invasive detection of iron deficiency in obstetrics (PICCOLINO Trial)

________________________________________ Brief Summary Iron deficiency is a common condition during pregnancy and is associated with maternal fatigue, increased need for blood transfusion during delivery, and adverse neonatal outcomes. However, current screening practices are inconsistent and often rely on imprecise laboratory parameters like hemoglobin and ferritin. The PICCOLINO trial is a prospective, longitudinal observational study investigating the feasibility and diagnostic value of a novel non-invasive fluorescence-based device to measure zinc protoporphyrin (ZnPP) at the lower lip as a screening tool for iron deficiency in pregnant women.

This study compares non-invasive ZnPP measurements with conventional blood-based markers for iron deficiency and anemia at five time points: once in each trimester, at the time of delivery, and approximately 2-3 months postpartum. The study further examines correlations between iron status and maternal well-being, postpartum depression, restless legs syndrome (RLS), and pregnancy complications.

________________________________________ Detailed Description The study enrolls up to 500 pregnant women, aiming to start inclusion as early as the first trimester. In each participant, ZnPP will be measured non-invasively at the lower lip using an optical sensor. Concurrently, venous blood samples will be drawn (where possible during routine care) to assess standard hematological and iron-related parameters (Hb, MCV, MCH, ferritin, transferrin saturation, Ret-Hb, RDW, and serum zinc).

Validated questionnaires will be used to assess:

• General health-related quality of life (SF-12)
• Postpartum depression (EPDS)
• Restless legs syndrome (IRLS)
• Nutrition and supplement intake
• Birth experience (SCIB) The primary aim is to validate the diagnostic performance of non-invasive ZnPP measurements as a screening tool for iron deficiency in pregnancy. Receiver operating characteristic (ROC) analysis will be conducted to compare non-invasive measurements with expert opinion diagnoses and blood-based markers. Secondary outcomes include the relationship between iron deficiency and maternal fatigue, mood disorders, pregnancy outcomes, and neonatal parameters.

Study Design

• Type: Observational (Longitudinal Cohort)
• Duration per participant: Up to 12 months
• Estimated Enrollment: 500 participants
• Timepoints: 1st, 2nd, 3rd trimester, peripartum, and 60-90 days postpartum
• Location: University Hospital Würzburg, Germany

Eligibility Criteria

Inclusion Criteria:

• Pregnant women aged ≥18 years
• Any gestational age or shortly postpartum
• Written informed consent

Exclusion Criteria:

• Previous participation in the study
• Decline of blood sampling for study purposes
• Inability to provide informed consent

Outcome Measures

Primary Outcome:

• Diagnostic performance (ROC/AUC) of non-invasive ZnPP in detecting iron deficiency

Secondary Outcomes:

• Correlation of iron status with quality of life, postpartum depression, and RLS
• Relationship between iron deficiency and pregnancy/neonatal complications

Conditions

Iron Deficiency Anemia of Pregnancy; Iron-deficiency; Restless Leg Syndrome in Pregnancy; Restless Leg Syndrome Due to Iron Deficiency Anaemia; Postpartum Hemorrhage; Postpartum Depression; Pregnancy Anemia; Iron Deficiency (Without Anemia)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

pregnant women

non-invasive measurement of zink protoporphyrin

Intervention Type: DIAGNOSTIC_TEST

validation of non-invasive measurement of zink protoporphyrin

Interventions

non-invasive measurement of zink protoporphyrin

validation of non-invasive measurement of zink protoporphyrin

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

blood samples; questionnaires

Eligibility Criteria

Inclusion Criteria

• any timepoint during or up to 3 months after pregnancy
• age ≥ 18 years
• written informed consent

Exclusion Criteria

• previous participation in this study
• refusal of blood sampling
• incapacity to give informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wuerzburg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Univ.-Prof. Dr. P. Kranke

Prof. Dr. P. Kranke

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Würzburg

Würzburg, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Peter Kranke, MD, MBA

Role: CONTACT

kranke_p@ukw.de

+4993120130050

Tobias Schlesinger, MD

Role: CONTACT

schlesinge_t@ukw.de

+4993120130380

Facility Contacts

Peter Kranke, MD, MBA, MME

Role: primary

kranke_p@ukw.de

+49-931 ext. 20130050

Eva-Maria Kranke, RN

Role: backup

kranke_e@ukw.de

+49-931 ext. 20130024

Other Identifiers

115/21-sc

Identifier Type: -

Identifier Source: org_study_id